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NCT Number: NCT02239523

Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis

Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.

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Key information

Conditions

Osteoporotic Fracture Bone Diseases Bone Diseases, Metabolic Fractures, Bone Fractures, Spontaneous Fractures, Stress Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporotic Fractures Wounds and Injuries

Age range

50 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

About this study

Patients who present to the orthopedic department in a level I trauma center will be prospectively randomized into one of two groups:

Letter Group: At time of discharge, patients will be sent home with a discharge letter that includes standard recommendations for evaluation and treatment. They will be asked to give the letter to their primary care physician.

Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet with explaining osteoporosis and the importance of treatment. The orthopedic department will perform a bone density testing (DEXA). They will be given a letter with a specific medication recommendation based on a protocol determined by our endocrinology department. They will be asked to give both DEXA and medication recommendation to their primary care doctor to initiate treatment. Finally, a research assistant will contact the patient monthly to encourage them to start treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients over age 50 with fragility fracture defined as a fall from standing or walking position

Exclusion criteria

  • Patients with metastatic cancer
  • Known metabolic bone disease
  • End-of-life care
  • Inability to provide consent
  • Known MRSA carriers
  • Fractures of the trochanter alone, shaft or peri-prosthetic fractures

Treatment and study plan

Letter Group

Procedure

At time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician.

Intervention group

Procedure

The orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment.

Other names: Intervention, Dual-energy X-ray absorptiometry, Bone density scan, Bisphosphonate, Prolia, Denosumab, Forteo, Teriparatide

Primary outcomes

  1. Percentage of patients with osteoporosis that are appropriately treated

    Time frame: Determination of proper treatment will be made at 4 months after the fracture.

    Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.

Secondary outcomes

  1. Percentage of patients who undergo DEXA scan.

    Time frame: Evaluation will be made 4 months after the initial fracture event.

    Whether or not the patients received the medication

Other outcomes

  1. Cost benefit analysis

    Time frame: Evaluation will be made at time of discharge and up to 4 months from the fracture event.

    Cost analysis will be made for each patient during the hospitalization and for 3 months after the fracture to capture complications related to the initial event.

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2014
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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